Within six months the military plans to begin implanting microchips on the surface of patients’ brains to study a prosthetic robotic arm controlled by the user’s thoughts, via the chip. The $100 million arm, which was developed over five years by the Pentagon’s Defense Advanced Research Projects Agency (DARPA), will also be the first device to be fast-tracked for review by the Food and Drug Administration (FDA) under its newly proposed “Innovation Pathway” initiative.
The FDA’s new measure is designed to spur innovation by speeding the review of the most pioneering and revolutionary new medical devices. The agency hopes to be able to review these devices in about five months, roughly half the time it currently takes to do so. (More on Time.com: Bionic Legs Allow Paraplegics to Get Up and Walk)
That means DARPA’s prosthetic arm could potentially be made available to amputees — many of whom are wounded veterans returning from combat — in as soon as four or five years.
To expedite reviews, the FDA will assign each device application a case manager, who will help guide the company through the regulatory system efficiently. Within 150 days of accepting a device application, the FDA will propose a roadmap and timeline for testing the device and for regulatory review.
The FDA proposed the Innovation Pathway in response to criticism from the medical device industry that its overly strict and sluggish system of evaluation was slowing advancement and hurting patients who could potentially be helped by new technologies. Of course, the FDA has also been condemned for approving some devices too easily and endangering patients. Now the agency’s goal is to streamline the regulatory process, without lowering safety standards for approval. (More on Time.com: VIDEO: Lebanon’s Landmine Soccer Team)
The Los Angeles Times reported:
[Jeffrey] Shuren, [head of the FDA's office of medical devices], said the innovation initiative had been in the works “for some time.” It was unveiled a day after President Obama told the U.S. Chamber of Commerce that “we’re improving the way FDA evaluates things like medical devices, to get innovative and lifesaving treatments to market faster.”
House Republicans are intent on framing the Obama administration as overseers of a job-sapping bureaucracy, and have scheduled a hearing Thursday on how government regulations are standing in the way of creating jobs.
But back to the robot.
The arm is silver and black, resembling a super hero’s limb, and can rotate, twist and bend in 27 different ways, mimicking the movements of a natural limb. In a video demonstrating the prosthetic arm’s dexterity, it performs small, complex tasks like picking up and squeezing a palm-sized football, manipulating a wrench and pinching open a clothespin. (More on Time.com: Cyberdyne’s Real Robot)
See the video below (the demonstration begins at minute 15):
The next step is to test the microchip, which records and issues commands based on signals from neurons, in a patient’s brain. According to the L.A. Times:
Five patients will initially be implanted with the chips and monitored for a year, said Mike McLoughlin, program manager for the prosthetics project at Johns Hopkins University, a major collaborator on the device. The use of chips to control artificial limbs is established technology, but the performance of the chips over time is an area of concern, McLoughlin said.
In some cases the body eventually rejects the chip as a foreign object, and in other cases the signal from the chip degrades, he said.
If the trial is successful and the system is made commercially available, it could help dramatically improve the lives of wounded or paralyzed soldiers, as well as stroke victims and other civilians who have lost the use of limbs.
Other devices developed by the military and adapted for those living with paralysis include a robotics system called HULC, for Human Universal Load Carrier, which was originally designed to help soldiers safely carry heavy packs across extreme terrain and long distances. The civilian device is called eLEGS.
The FDA’s Innovation Pathway is still in the proposal stage and will be subject to public comment. A meeting is scheduled for March 15.